Chikungunya Virus Infection
Conditions
Keywords
Chikungunya, infectious disease
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels.
Detailed description
This is a double blinded, block-randomized, active- and placebo controlled, phase II trial, comparing two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK (a novel vaccine against Chikungunya virus). Healthy male and female subjects aged 18-55 years will be randomized to one of six treatment groups (A, B, C. D, M1 or M2) differing in dosage and scheduling of vaccinations. Group A-D will be split in one arm receiving MV-CHIK and one control-arm receiving Priorix®. All subjects of group A. B, C and D will receive three i.m. injections on study day 0, 28 and 196. Subjects of group A and B will receive MV-CHIK low dose or control-vaccine Priorix® (or equivalent measles vaccine) and subjects of group C and D will be treated with MV-CHIK high dose or control-vaccine (Priorix® or equivalent measles vaccine). All subjects of group A, B, C and D additionally will be randomized to one of two treatment sequences: group A and C will receive MV-CHIK or control-vaccine Priorix® on study day 0 and 28, followed by placebo on day 196, and group B and D receive placebo on day 0 and MV-CHIK or Priorix® on day 28, followed by an additional vaccination of the same product on day196 (boosting vaccination). All subjects of the measles booster group M1 and M2 will receive five i.m. injections on study day -28, 0, 28, 168 and 196. The first vaccination will be Priorix® (or equivalent measles vaccine) on study day -28. Group M1 will receive MV-CHIK vaccinations on day 0 and day 28 and placebo on day 168 and 196. Group M2 will receive placebo on day 0 and 28 and MV-CHIK on day 168 and on day 196. All subjects will be followed for safety and immunogenicity evaluation until day 224. Study duration per subject is estimated to be 33-37 weeks (\ 8 months), respectively.
Interventions
BIOLOGICALMV-CHIK low dose
recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
BIOLOGICALMV-CHIK high dose
recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose
BIOLOGICALPriorix®
lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection
BIOLOGICALphysiological saline solution
sterile physiological saline solution 0.9% used as placebo
Sponsors
Themis Bioscience GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent obtained before any trial-related activities. 2. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study 3. Available for the duration of the trial 4. Healthy men or women aged \>18 and \<55 years 5. In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception as specified in protocol 6. Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant 7. Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in
Exclusion criteria
)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Study day 56 (28 days after one or two vaccinations depending on treatment group). | Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Baseline until study day 56 | Determination of anti-measles antibodies on day 0, 28, and 56; additionally for group M1 and M2 on day -28 by enzyme linked immunosorbent assay (ELISA). |
| Number of Participants With Solicited Local and Systemic Adverse Events | Solicited adverse events were recorded for 7 days after each vaccination | Evaluation of solicited local and systemic adverse events as recorded in the subjects' diaries for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations. |
| Number of Participants Who Experienced Treatment Emergent Adverse Events | First vaccination until study day 224 | Evaluation of all treatment emergent adverse events (TEAEs) occurred throughout the clinical study. Clinically relevant abnormal safety laboratory values were recorded as TEAEs. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations. |
| Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196 | Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in urine by polymerase chain reaction (PCR). |
| Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Baseline until study day 224 | Evaluation of immunogenicity on day 0, 28, 196 and 224; additionally for group M1 and M2 on day 168 as confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50). |
| Chikungunya Virus Specific T Cell Responses | Baseline until study day 224 | Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood to determine functional IL-2-producing T cells on day 0, 28, 56 and 224 in a subset of subjects. ELISpots were performed using peptides covering the CHIK proteins E1, E2 and C for re-stimulation, thereby producing three values per sample representing the number of spots per 1 x 10\^6 PBMCs. If one or more of the three values was greater than 50, the sample was considered positive and the highest of the three values was used in the analysis. If all three values were below 50, the sample was considered negative and a value of 0.0 was used for analysis. |
| Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224 | Evaluation of immunogenicity mediated by serum IgG antibodies against Chikungunya on days 0, 28, 196 and 224; additionally for group M1 and M2 on day 168, determined by enzyme linked immunosorbent assay (ELISA). |
| Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer | Study day 56 (28 days after one or two vaccinations depending on treatment group) | To determine the potential impact of pre-existing antibodies against measles on MV-CHIK immunogenicity, participants from treatment Groups A to D were divided into quartiles according to serum IgG concentrations against measles virus on Day 0. Functional anti-chikungunya antibodies as determined by PRNT50 were compared between groups. |
| Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196 | Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in saliva by polymerase chain reaction (PCR). |
Countries
Austria, Germany
Participant flow
Recruitment details
322 participants screened for eligibility, 263 participants randomized
Pre-assignment details
59 screening failures (33 withdrawal of consent, 26 violation of in-/exclusion criteria)
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group A; MV-CHIK Low Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 51 |
| Treatment Group A/C; Priorix® Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 18 |
| Treatment Group B; MV-CHIK Low Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 47 |
| Treatment Group B/D; Priorix® Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 16 |
| Treatment Group C; MV-CHIK High Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 47 |
| Treatment Group D; MV-CHIK High Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 50 |
| Measles Booster Group 1 Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 18 |
| Measles Booster Group 2 Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo | 16 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 1 | 0 | 0 | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment Group A; MV-CHIK Low | Total | Measles Booster Group 2 | Measles Booster Group 1 | Treatment Group D; MV-CHIK High | Treatment Group C; MV-CHIK High | Treatment Group B/D; Priorix® | Treatment Group B; MV-CHIK Low | Treatment Group A/C; Priorix® |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 10.13 | 32.5 years STANDARD_DEVIATION 10.65 | 32.6 years STANDARD_DEVIATION 10.28 | 31.1 years STANDARD_DEVIATION 10.41 | 31.2 years STANDARD_DEVIATION 9.93 | 35.1 years STANDARD_DEVIATION 12.32 | 33.6 years STANDARD_DEVIATION 11.56 | 32.7 years STANDARD_DEVIATION 10.53 | 32.2 years STANDARD_DEVIATION 10.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 257 Participants | 16 Participants | 17 Participants | 49 Participants | 45 Participants | 16 Participants | 47 Participants | 17 Participants |
| Sex: Female, Male Female | 27 Participants | 140 Participants | 5 Participants | 11 Participants | 27 Participants | 24 Participants | 7 Participants | 29 Participants | 10 Participants |
| Sex: Female, Male Male | 24 Participants | 123 Participants | 11 Participants | 7 Participants | 23 Participants | 23 Participants | 9 Participants | 18 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 18 | 0 / 47 | 0 / 16 | 0 / 47 | 0 / 50 | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 40 / 51 | 14 / 18 | 36 / 47 | 11 / 16 | 38 / 47 | 41 / 50 | 15 / 18 | 14 / 16 |
| serious Total, serious adverse events | 1 / 51 | 1 / 18 | 2 / 47 | 1 / 16 | 0 / 47 | 1 / 50 | 0 / 18 | 0 / 16 |
Outcome results
Primary
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.
Time frame: Study day 56 (28 days after one or two vaccinations depending on treatment group).
Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 50.2 Titer | Standard Deviation 127.69 |
| Treatment Group A/C; Priorix® | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 5.0 Titer | Standard Deviation 0 |
| Treatment Group B; MV-CHIK Low | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 12.9 Titer | Standard Deviation 100.47 |
| Treatment Group B/D; Priorix® | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 5.0 Titer | Standard Deviation 0 |
| Treatment Group C; MV-CHIK High | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 174.8 Titer | Standard Deviation 436.11 |
| Treatment Group D; MV-CHIK High | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 33.6 Titer | Standard Deviation 59.38 |
| Measles Booster Group 1 | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 80.0 Titer | Standard Deviation 233.8 |
| Measles Booster Group 2 | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 5.0 Titer | Standard Deviation 0 |
p-value: <0.000195% CI: [2, 7.7]ANOVA
p-value: <0.000195% CI: [0.1, 0.6]ANOVA
p-value: 0.633495% CI: [0.8, 3]ANOVA
p-value: 0.806595% CI: [0.2, 1.6]ANOVA
p-value: <0.000195% CI: [3.8, 26.6]ANOVA
p-value: <0.000195% CI: [0, 0.3]ANOVA
p-value: <0.000195% CI: [0, 0.3]ANOVA
p-value: <0.000195% CI: [0, 0.1]ANOVA
p-value: 0.001195% CI: [0.2, 0.8]ANOVA
p-value: <0.000195% CI: [0.1, 0.4]ANOVA
p-value: 0.071895% CI: [1, 6.9]ANOVA
p-value: 0.059395% CI: [0.1, 1]ANOVA
p-value: 0.059395% CI: [0.1, 1]ANOVA
p-value: <0.000195% CI: [2.6, 10.4]ANOVA
p-value: 0.200595% CI: [0.8, 5.7]ANOVA
p-value: <0.000195% CI: [13.1, 93.1]ANOVA
p-value: <0.000195% CI: [0, 0.1]ANOVA
p-value: <0.00010% CI: [0, 0.1]ANOVA
p-value: 0.113895% CI: [0.2, 1.1]ANOVA
p-value: <0.000195% CI: [2.5, 18.1]ANOVA
p-value: <0.000195% CI: [0.1, 0.4]ANOVA
p-value: <0.000195% CI: [0.1, 0.4]ANOVA
p-value: <0.000195% CI: [4.9, 52.4]ANOVA
p-value: <0.000195% CI: [0, 0.2]ANOVA
p-value: <0.000195% CI: [0, 0.2]ANOVA
p-value: 195% CI: [0.3, 3.3]ANOVA
p-value: 195% CI: [0.3, 3.3]ANOVA
p-value: 195% CI: [0.3, 3.2]ANOVA
Secondary
Chikungunya Virus Specific T Cell Responses
Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood to determine functional IL-2-producing T cells on day 0, 28, 56 and 224 in a subset of subjects. ELISpots were performed using peptides covering the CHIK proteins E1, E2 and C for re-stimulation, thereby producing three values per sample representing the number of spots per 1 x 10\^6 PBMCs. If one or more of the three values was greater than 50, the sample was considered positive and the highest of the three values was used in the analysis. If all three values were below 50, the sample was considered negative and a value of 0.0 was used for analysis.
Time frame: Baseline until study day 224
Population: A subset of the mITT Population was analyzed for T-cell Response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Chikungunya Virus Specific T Cell Responses | Visit 2 /day 28 | 41.5 Titer | Standard Deviation 128.71 |
| Treatment Group A; MV-CHIK Low | Chikungunya Virus Specific T Cell Responses | Visit 1 /day 0 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group A; MV-CHIK Low | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 28.3 Titer | Standard Deviation 48.92 |
| Treatment Group A; MV-CHIK Low | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 46.5 Titer | Standard Deviation 63.54 |
| Treatment Group A/C; Priorix® | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group A/C; Priorix® | Chikungunya Virus Specific T Cell Responses | Visit 1 /day 0 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group A/C; Priorix® | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group A/C; Priorix® | Chikungunya Virus Specific T Cell Responses | Visit 2 /day 28 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group B; MV-CHIK Low | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 71.8 Titer | Standard Deviation 133.03 |
| Treatment Group B; MV-CHIK Low | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 36.7 Titer | Standard Deviation 68.41 |
| Treatment Group B; MV-CHIK Low | Chikungunya Virus Specific T Cell Responses | Visit 1 /day 0 | 12.1 Titer | Standard Deviation 40.1 |
| Treatment Group B/D; Priorix® | Chikungunya Virus Specific T Cell Responses | Visit 1 /day 0 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group B/D; Priorix® | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 25.2 Titer | Standard Deviation 56.35 |
| Treatment Group B/D; Priorix® | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 13.2 Titer | Standard Deviation 29.52 |
| Treatment Group C; MV-CHIK High | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 53.4 Titer | Standard Deviation 74.38 |
| Treatment Group C; MV-CHIK High | Chikungunya Virus Specific T Cell Responses | Visit 1 /day 0 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group C; MV-CHIK High | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 11.6 Titer | Standard Deviation 23.06 |
| Treatment Group C; MV-CHIK High | Chikungunya Virus Specific T Cell Responses | Visit 2 /day 28 | 10.5 Titer | Standard Deviation 39.29 |
| Treatment Group D; MV-CHIK High | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 6.5 Titer | Standard Deviation 21.41 |
| Treatment Group D; MV-CHIK High | Chikungunya Virus Specific T Cell Responses | Visit 1 /day 0 | 0.0 Titer | Standard Deviation 0 |
| Treatment Group D; MV-CHIK High | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 30.1 Titer | Standard Deviation 61.48 |
| Measles Booster Group 1 | Chikungunya Virus Specific T Cell Responses | Visit 1 /day 0 | 0.0 Titer | Standard Deviation 0 |
| Measles Booster Group 1 | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 0.0 Titer | Standard Deviation 0 |
| Measles Booster Group 1 | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 47.0 Titer | Standard Deviation 51.55 |
| Measles Booster Group 2 | Chikungunya Virus Specific T Cell Responses | Visit 3 /day 56 | 0.0 Titer | Standard Deviation 0 |
| Measles Booster Group 2 | Chikungunya Virus Specific T Cell Responses | Visit 6 /day 224 | 0.0 Titer | Standard Deviation 0 |
Secondary
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer
To determine the potential impact of pre-existing antibodies against measles on MV-CHIK immunogenicity, participants from treatment Groups A to D were divided into quartiles according to serum IgG concentrations against measles virus on Day 0. Functional anti-chikungunya antibodies as determined by PRNT50 were compared between groups.
Time frame: Study day 56 (28 days after one or two vaccinations depending on treatment group)
Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer | 155.1 Titer | Standard Deviation 532.68 |
| Treatment Group A/C; Priorix® | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer | 177.0 Titer | Standard Deviation 897.74 |
| Treatment Group B; MV-CHIK Low | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer | 117.6 Titer | Standard Deviation 346.86 |
| Treatment Group B/D; Priorix® | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer | 100.8 Titer | Standard Deviation 535.78 |
p-value: 0.977595% CI: [0.4, 2]ANOVA
p-value: 0.836695% CI: [0.6, 3.1]ANOVA
p-value: 0.562595% CI: [0.7, 3.6]ANOVA
p-value: 0.592495% CI: [0.6, 3.5]ANOVA
p-value: 0.312295% CI: [0.8, 4.1]ANOVA
p-value: 0.966595% CI: [0.5, 2.8]ANOVA
Secondary
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Evaluation of immunogenicity on day 0, 28, 196 and 224; additionally for group M1 and M2 on day 168 as confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50).
Time frame: Baseline until study day 224
Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.1 Titer | Standard Deviation 0.71 |
| Treatment Group A; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 13.5 Titer | Standard Deviation 33.46 |
| Treatment Group A; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 11.2 Titer | Standard Deviation 63.4 |
| Treatment Group A; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 14.6 Titer | Standard Deviation 37.87 |
| Treatment Group A/C; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group A/C; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group A/C; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group A/C; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group B; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.3 Titer | Standard Deviation 3.16 |
| Treatment Group B; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 70.5 Titer | Standard Deviation 174.57 |
| Treatment Group B; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 6.4 Titer | Standard Deviation 8.29 |
| Treatment Group B; MV-CHIK Low | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 5.5 Titer | Standard Deviation 3.82 |
| Treatment Group B/D; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group B/D; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group B/D; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group B/D; Priorix® | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 5.00 Titer | Standard Deviation 0 |
| Treatment Group C; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 25.7 Titer | Standard Deviation 52.22 |
| Treatment Group C; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 41.8 Titer | Standard Deviation 105.55 |
| Treatment Group C; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 38.8 Titer | Standard Deviation 70.59 |
| Treatment Group C; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group D; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 5.1 Titer | Standard Deviation 0.75 |
| Treatment Group D; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 609.8 Titer | Standard Deviation 949.7 |
| Treatment Group D; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.0 Titer | Standard Deviation 0 |
| Treatment Group D; MV-CHIK High | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 16.5 Titer | Standard Deviation 81.75 |
| Measles Booster Group 1 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 24.1 Titer | Standard Deviation 106.25 |
| Measles Booster Group 1 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.0 Titer | Standard Deviation 0 |
| Measles Booster Group 1 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 18.3 Titer | Standard Deviation 87.5 |
| Measles Booster Group 1 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 13.5 Titer | Standard Deviation 40.52 |
| Measles Booster Group 1 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 4 /day 168 | 28.9 Titer | Standard Deviation 52.25 |
| Measles Booster Group 2 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 6 /day 224 | 66.5 Titer | Standard Deviation 172.62 |
| Measles Booster Group 2 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 1 /day 0 | 5.0 Titer | Standard Deviation 0 |
| Measles Booster Group 2 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 2 /day 28 | 5.0 Titer | Standard Deviation 0 |
| Measles Booster Group 2 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 4 /day 168 | 5.0 Titer | Standard Deviation 0 |
| Measles Booster Group 2 | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | Visit 5 /day 196 | 11.5 Titer | Standard Deviation 26.04 |
Secondary
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA)
Evaluation of immunogenicity mediated by serum IgG antibodies against Chikungunya on days 0, 28, 196 and 224; additionally for group M1 and M2 on day 168, determined by enzyme linked immunosorbent assay (ELISA).
Time frame: Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224
Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 2.1 Titer | Standard Deviation 1.94 |
| Treatment Group A; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 5.6 Titer | Standard Deviation 16.04 |
| Treatment Group A; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 13.6 Titer | Standard Deviation 31.84 |
| Treatment Group A; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 3.2 Titer | Standard Deviation 6.57 |
| Treatment Group A; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 4.6 Titer | Standard Deviation 9.46 |
| Treatment Group A/C; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 3.4 Titer | Standard Deviation 3.13 |
| Treatment Group A/C; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 3.1 Titer | Standard Deviation 4.66 |
| Treatment Group A/C; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 3.3 Titer | Standard Deviation 4.02 |
| Treatment Group A/C; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 3.4 Titer | Standard Deviation 4.06 |
| Treatment Group A/C; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 3.6 Titer | Standard Deviation 3.64 |
| Treatment Group B; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 2.2 Titer | Standard Deviation 1.81 |
| Treatment Group B; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 2.3 Titer | Standard Deviation 1.68 |
| Treatment Group B; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 3.4 Titer | Standard Deviation 6.26 |
| Treatment Group B; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 3.0 Titer | Standard Deviation 3.11 |
| Treatment Group B; MV-CHIK Low | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 25.4 Titer | Standard Deviation 52.43 |
| Treatment Group B/D; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 1.9 Titer | Standard Deviation 2.06 |
| Treatment Group B/D; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 1.7 Titer | Standard Deviation 1.63 |
| Treatment Group B/D; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 1.7 Titer | Standard Deviation 1.82 |
| Treatment Group B/D; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 2.0 Titer | Standard Deviation 2.75 |
| Treatment Group B/D; Priorix® | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 1.7 Titer | Standard Deviation 1.05 |
| Treatment Group C; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 15.2 Titer | Standard Deviation 25.08 |
| Treatment Group C; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 74.4 Titer | Standard Deviation 41.45 |
| Treatment Group C; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 2.3 Titer | Standard Deviation 2.75 |
| Treatment Group C; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 6.2 Titer | Standard Deviation 4.65 |
| Treatment Group C; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 13.1 Titer | Standard Deviation 24.24 |
| Treatment Group D; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 2.5 Titer | Standard Deviation 1.74 |
| Treatment Group D; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 2.2 Titer | Standard Deviation 1.53 |
| Treatment Group D; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 5.6 Titer | Standard Deviation 21.33 |
| Treatment Group D; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 6.6 Titer | Standard Deviation 18.68 |
| Treatment Group D; MV-CHIK High | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 130.8 Titer | Standard Deviation 43.94 |
| Measles Booster Group 1 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 4.3 Titer | Standard Deviation 9.48 |
| Measles Booster Group 1 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 7.3 Titer | Standard Deviation 28.56 |
| Measles Booster Group 1 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 28.0 Titer | Standard Deviation 47.51 |
| Measles Booster Group 1 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 4 /day 168 | 9.5 Titer | Standard Deviation 29.82 |
| Measles Booster Group 1 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 2.4 Titer | Standard Deviation 2.69 |
| Measles Booster Group 1 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 8.9 Titer | Standard Deviation 24.13 |
| Measles Booster Group 2 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 5 /day 196 | 3.6 Titer | Standard Deviation 5.48 |
| Measles Booster Group 2 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 6 /day 224 | 20.4 Titer | Standard Deviation 43.19 |
| Measles Booster Group 2 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 4 /day 168 | 1.8 Titer | Standard Deviation 2.28 |
| Measles Booster Group 2 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 3 /day 56 | 2.3 Titer | Standard Deviation 2.1 |
| Measles Booster Group 2 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 1 /day 0 | 2.2 Titer | Standard Deviation 2.25 |
| Measles Booster Group 2 | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | Visit 2 /day 28 | 2.0 Titer | Standard Deviation 2.37 |
Secondary
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay
Determination of anti-measles antibodies on day 0, 28, and 56; additionally for group M1 and M2 on day -28 by enzyme linked immunosorbent assay (ELISA).
Time frame: Baseline until study day 56
Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 1651.8 Titer | Standard Deviation 1384.39 |
| Treatment Group A; MV-CHIK Low | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 456.2 Titer | Standard Deviation 1398.54 |
| Treatment Group A; MV-CHIK Low | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 1509.4 Titer | Standard Deviation 1360.83 |
| Treatment Group A/C; Priorix® | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 1200.6 Titer | Standard Deviation 1129.77 |
| Treatment Group A/C; Priorix® | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 693.9 Titer | Standard Deviation 1307.42 |
| Treatment Group A/C; Priorix® | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 1129.4 Titer | Standard Deviation 1168.63 |
| Treatment Group B; MV-CHIK Low | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 396.9 Titer | Standard Deviation 1183.04 |
| Treatment Group B; MV-CHIK Low | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 1255.0 Titer | Standard Deviation 1279.28 |
| Treatment Group B; MV-CHIK Low | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 398.1 Titer | Standard Deviation 1267.55 |
| Treatment Group B/D; Priorix® | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 673.8 Titer | Standard Deviation 917.52 |
| Treatment Group B/D; Priorix® | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 390.4 Titer | Standard Deviation 1106.86 |
| Treatment Group B/D; Priorix® | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 447.5 Titer | Standard Deviation 1139.37 |
| Treatment Group C; MV-CHIK High | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 495.0 Titer | Standard Deviation 1181.36 |
| Treatment Group C; MV-CHIK High | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 2343.9 Titer | Standard Deviation 1357.29 |
| Treatment Group C; MV-CHIK High | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 2750.5 Titer | Standard Deviation 1284.23 |
| Treatment Group D; MV-CHIK High | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 2435.2 Titer | Standard Deviation 1461.78 |
| Treatment Group D; MV-CHIK High | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 492.1 Titer | Standard Deviation 1227.24 |
| Treatment Group D; MV-CHIK High | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 401.8 Titer | Standard Deviation 1073.54 |
| Measles Booster Group 1 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 0 / day -28 | 542.6 Titer | Standard Deviation 1118.52 |
| Measles Booster Group 1 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 785.6 Titer | Standard Deviation 1149.47 |
| Measles Booster Group 1 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 1761.5 Titer | Standard Deviation 1578.85 |
| Measles Booster Group 1 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 1825.2 Titer | Standard Deviation 1459.93 |
| Measles Booster Group 2 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 1 / day 0 | 645.9 Titer | Standard Deviation 850.56 |
| Measles Booster Group 2 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 0 / day -28 | 304.5 Titer | Standard Deviation 343.53 |
| Measles Booster Group 2 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 3 / day 56 | 521.4 Titer | Standard Deviation 455.37 |
| Measles Booster Group 2 | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | Visit 2 / day 28 | 561.2 Titer | Standard Deviation 385.36 |
Secondary
Number of Participants Who Experienced Treatment Emergent Adverse Events
Evaluation of all treatment emergent adverse events (TEAEs) occurred throughout the clinical study. Clinically relevant abnormal safety laboratory values were recorded as TEAEs. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Time frame: First vaccination until study day 224
Population: All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 1 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 29 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 8 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 12 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 1 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 2 Participants |
| Treatment Group A/C; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 1 Participants |
| Treatment Group A/C; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 1 Participants |
| Treatment Group A/C; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 3 Participants |
| Treatment Group A/C; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 10 Participants |
| Treatment Group A/C; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 2 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 27 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 11 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 15 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 1 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 2 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 2 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 2 Participants |
| Treatment Group B/D; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 1 Participants |
| Treatment Group B/D; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 1 Participants |
| Treatment Group B/D; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 7 Participants |
| Treatment Group B/D; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 1 Participants |
| Treatment Group B/D; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 1 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 4 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 22 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 9 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 10 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 1 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 8 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 2 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 1 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 1 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 18 Participants |
| Measles Booster Group 1 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 1 Participants |
| Measles Booster Group 1 | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 2 Participants |
| Measles Booster Group 1 | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 0 Participants |
| Measles Booster Group 1 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 0 Participants |
| Measles Booster Group 1 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 4 Participants |
| Measles Booster Group 1 | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 11 Participants |
| Measles Booster Group 1 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 4 Participants |
| Measles Booster Group 2 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Medically attended TEAEs | 3 Participants |
| Measles Booster Group 2 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Serious TEAEs | 0 Participants |
| Measles Booster Group 2 | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs | 9 Participants |
| Measles Booster Group 2 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Related TEAEs | 5 Participants |
| Measles Booster Group 2 | Number of Participants Who Experienced Treatment Emergent Adverse Events | Severe TEAEs | 1 Participants |
| Measles Booster Group 2 | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs where an action was taken | 0 Participants |
| Measles Booster Group 2 | Number of Participants Who Experienced Treatment Emergent Adverse Events | TEAEs of special interest | 0 Participants |
Secondary
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196
Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in saliva by polymerase chain reaction (PCR).
Time frame: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Population: As subjects of the measles booster groups M1 and M2 received a measles vaccination prior to the modified MV-CHIK vaccine, these groups had to be excluded from measles shedding analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 7 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 10 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 5/Day 196 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Day 14 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 2/Day 28 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 | Visit 1/Day 0 | 0 Participants |
Secondary
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196
Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in urine by polymerase chain reaction (PCR).
Time frame: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Population: As subjects of the measles booster groups M1 and M2 received a measles vaccination prior to the modified MV-CHIK vaccine, these groups had to be excluded from measles shedding analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Treatment Group A; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Measles Booster Group 1 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 1 /day 0 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 10 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 7 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 5 /day 196 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | day 14 | 0 Participants |
| Measles Booster Group 2 | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 | Visit 2 /day 28 | 0 Participants |
Secondary
Number of Participants With Solicited Local and Systemic Adverse Events
Evaluation of solicited local and systemic adverse events as recorded in the subjects' diaries for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Time frame: Solicited adverse events were recorded for 7 days after each vaccination
Population: All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group A; MV-CHIK Low | Number of Participants With Solicited Local and Systemic Adverse Events | 35 Participants |
| Treatment Group A/C; Priorix® | Number of Participants With Solicited Local and Systemic Adverse Events | 14 Participants |
| Treatment Group B; MV-CHIK Low | Number of Participants With Solicited Local and Systemic Adverse Events | 32 Participants |
| Treatment Group B/D; Priorix® | Number of Participants With Solicited Local and Systemic Adverse Events | 10 Participants |
| Treatment Group C; MV-CHIK High | Number of Participants With Solicited Local and Systemic Adverse Events | 37 Participants |
| Treatment Group D; MV-CHIK High | Number of Participants With Solicited Local and Systemic Adverse Events | 41 Participants |
| Measles Booster Group 1 | Number of Participants With Solicited Local and Systemic Adverse Events | 13 Participants |
| Measles Booster Group 2 | Number of Participants With Solicited Local and Systemic Adverse Events | 10 Participants |